職位描述

The Integrated Management System Specialist is responsible for executing, maintaining and improving the quality management system and processes in DME to ensure the quality system complies with regulatory requirements internally and externally and keeps quality system continuing suitability, adequacy and effectiveness.

崗位職責

Quality system process Review –DME
-Collect and feedback to headquarter based on the quality system process generated by headquarter in combination with the local legal requirement.
-Conduct quality system processes training to local process owners according to the final released quality system processes.
-Maintain the master record of quality policy, quality procedures, working instructions, technical documents and other quality related records

Quality system regulatory compliance
-Analyze and give valuable suggestions to fulfill the gaps based on the updated quality system regulatory information.
-Execute quality related activities to ensure the quality system complies with relevant international and national standards and regulations, such as ISO 9001, ISO 13485, MDD 93/42/EEC, 21 CFR Part 820, China GMP etc.
-Assist the implementation of the current and updated regulation and standards within the organization
-Maintain and update all controlled files and records to ensure compliance with quality system requirements
-Collect data and generate reports of the quality system Key Performance Indicator and Management Review on regular basis

Audit Management
-Conduct self- inspection as the pre-internal audit within DME and perform the internal audit according to the audit program
-Support the external audit from Notified Body or authority
-Define, implement and follow-up systematic observations or corrective and preventive s (CAPA) if requires.

Quality System Regulation Training
-Support to conduct the internal quality system regulation training as a backup.

Others
-Assist and support the quality system related software validation.

任職要求

Bachelor degree in science and technology or a comparable combination of education and experience

3-5 years of experience in quality system management

Professional
-Knowledge of EC, EN, QSR and local target Market requirements – basic level
-Knowledge of FDA 21 CFR Part 820 – basic level
-Knowledge of ISO9001, 13485, MDD and 21CFR – advanced level
-English in written and spoken – advanced level
-MS Office – advanced level
Behavioral
-Cooperate and communicate – advanced level
-Act reliably – advanced level
-Learn and develop – advanced level
-Pay attention to detail – advanced level
-Solve problems – advanced level

德爾格是醫療和安全技術的國際先行者。德爾格 于 1889 成立于呂貝克，作為一個家族經營的企業已經歷經第五代，走向了全球并且列入 DAX 指數。我們的長期成功來自于以價值為中心的公司文化和四種核心優勢：與客戶緊密合作、員工的專業知識、不斷創新和卓越的質量。